FDA.reportPublic FDA data

carisoprodol

Product NDC
68071-3421
11-digit product format
680713421
Labeler code
68071
Product ID
68071-3421_2d584ea9-407f-a440-e063-6294a90a48cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
carisoprodol
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA040792
Marketing category
ANDA
Marketing start
2009-08-06
Substance
CARISOPRODOL
Active strength
350 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
carisoprodol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARISOPRODOL350 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii21925K482H
Rxcui197446

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
780d53a1-1665-e26e-d112-85333c0c8a2eProduct name520220516
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-3421-62025-02-04C16284748780-12cef2736-7c87-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use CARISOPRODOL TABLETS safely and effectively. See full prescribing information for CARISOPRODOL TABLETS. CARISOPRODOL tablets, for oral use CIV Initial U.S. Approval: 1959
68071-3421-62025-01-30C16284748780-12cef2736-7c87-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use CARISOPRODOL TABLETS safely and effectively. See full prescribing information for CARISOPRODOL TABLETS. CARISOPRODOL tablets, for oral use CIV Initial U.S. Approval: 1959

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3421-6carisoprodol60 in 1 BOTTLETABLET602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3421CARISOPRODOL TABLET [NUCARE PHARMACEUTICALS,INC.]2Current NDC, 1 package rows20250206_fd03c357-b199-c2b2-e053-6294a90abe2e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197446carisoprodol 350 MG Oral TabletPSNfd03c357-b199-c2b2-e053-6294a90abe2e2
197446carisoprodol 350 MG Oral TabletSCDfd03c357-b199-c2b2-e053-6294a90abe2e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3421-66807134210660 TABLET in 1 BOTTLE (68071-3421-6) 60 tablet2023-05-31NoNoCurrent